Safety and Efficacy Evaluation of S (+) - Ketamine in Children

• Status: Not yet recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

A multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of S (+) -ketamine for postoperative acute pain in children in perioperative settings.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese PLA General Hospital
• Collaborators: Beijing Children's Hospital; Hunan Children's Hospital; Shanghai Children's Medical Center; Southern Medical University, China
• Treatments: Esketamine; Ketamine

Criteria

Inclusion Criteria:

1. Age ≤17 years;

2. Scheduled for elective digestive tract surgery, orthopedic surgery, urological surgery or ear surgery under general anesthesia;

3. ASA physical status I～Ⅲ;

4. The informed consent form was signed by the patients or the guardians.

Exclusion Criteria:

1. The expected length of hospital stay of the patient is less than 48h;

2. Patients expected to be admitted to the ICU after surgery;

3. Patients expected to return to the ward with tracheal catheter after surgery;

4. Be allergic to S (+) - ketamine;

5. Patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;

6. Patients with congenital heart disease or severely developmental retardation;

7. Patients with any of the following contraindications of S (+) - ketamine:

1. Patients with risk of serious rise of blood pressure or intracranial pressure;

2. Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma;

3. Patients with poorly controlled or untreated hypertension (Resting systolic blood pressure greater than 180 mmHg, or resting diastolic blood pressure greater than 100mmHg);

4. Patients with untreated or undertreated hyperthyroidism.